Non-Operative Management Approaches for Urinary Incontinence

ED
EK
Overseen ByElisar Khawam
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University Hospitals Cleveland Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to manage urinary incontinence in women without surgery. It evaluates the effectiveness of different combinations of patient education, nurse support, and a ChatBot (an interactive digital assistant) in improving symptoms. Participants will be divided into three groups to test these approaches. Women visiting a primary care provider at University Hospitals Cleveland who experience any level of urinary incontinence may be suitable for this trial. As an unphased trial, it offers participants the chance to explore innovative, non-surgical solutions for urinary incontinence.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that nurse guidance is generally well-received for managing urinary incontinence in women. Studies have found that nurse-led programs help women care for themselves and manage symptoms effectively. No major side effects have been reported, making this a safe option for many.

Regarding chatbots, studies provide real-world evidence supporting their safety and effectiveness. Chatbots help patients understand and manage their condition better. They are easy to use and safe, with no significant risks reported.

Patient education is a common and safe approach, focusing on teaching patients about their condition and how to manage it. This method has been widely used without any serious safety concerns.

Overall, current research considers these treatments—nurse guidance, chatbots, and patient education—safe and well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about these non-operative management approaches for urinary incontinence because they offer innovative ways to support patients without surgery or medication. The combination of patient education with nurse navigation stands out by providing personalized guidance and support, helping patients better manage their condition. Adding a ChatBot to the mix introduces a modern, accessible way for patients to get real-time information and support, making it easier to stay informed and engaged in their care. These approaches aim to empower patients with tools and knowledge, potentially improving their quality of life with minimal intervention.

What evidence suggests that this trial's treatments could be effective for urinary incontinence?

This trial will explore various non-operative management approaches for urinary incontinence. Participants in Arm 1 will receive Patient Education, which research has shown can significantly reduce instances of urinary incontinence. In one study, 61% of participants experienced at least a 50% reduction in incontinence episodes after receiving educational support.

Arm 2 will combine Patient Education with Nurse Navigation. Adding guidance from nurses appears to enhance outcomes, particularly for nursing home residents, by improving their ability to manage incontinence.

Arm 3 will include Patient Education, Nurse Navigation, and a ChatBot. Early results suggest that chatbots effectively address common questions about urinary incontinence and provide helpful information. This approach aims to equip women with practical knowledge and support, potentially leading to better management of urinary incontinence.678910

Who Is on the Research Team?

AH

Adonis Hijaz, MD

Principal Investigator

University Hospitals Cleveland Medical Center

GR

Goutham Rao, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for women over 18 who are experiencing urinary incontinence and have visited the University Hospitals Cleveland Primary Care Institute. Participants should score at least 1 on a specific questionnaire about incontinence.

Inclusion Criteria

I am a woman who has seen a doctor at UH Cleveland's Primary Care Institute.
You score 1 or higher on a questionnaire about urinary incontinence.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants are assigned to one of three groups: Usual Care plus Patient Educational Opportunities, Nurse Navigation, or Nurse Navigation and ChatBot, with ongoing management and education

6-18 months
Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for adherence to therapy and improvement in symptoms, with data collection from medical records and questionnaires

6 months
Questionnaires and data collection

What Are the Treatments Tested in This Trial?

Interventions

  • ChatBot
  • Nurse Navigation
  • Patient Education
Trial Overview The EMPOWER study aims to enhance the diagnosis and non-surgical treatment of urinary incontinence among women, using patient education, nurse-led guidance, and a ChatBot to provide support.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Arm 3Experimental Treatment3 Interventions
Group II: Arm 2Experimental Treatment2 Interventions
Group III: Arm 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+

Adonis Hijaz, MD

Lead Sponsor

Trials
1
Recruited
400+

Citations

Urinary Incontinence - StatPearls - NCBI Bookshelf - NIHPatient education also encompasses understanding the types and causes of incontinence, managing fluid intake, and recognizing symptoms early.
The Effects of Education About Urinary Incontinence on ...Eleven of the 19 studies reported the statistical effect of education on patient outcomes. Uncontrolled trials reported improvements in nursing home residents' ...
The Effects of Education About Urinary Incontinence on ...Similarly, 2 studies set in inpatient rehabilitation found no significant differences in patient continence outcomes following an educational intervention ...
Evaluating the Effectiveness of Therapies for Urinary ...Subjective criteria, behavioral/emotional factors, and quality-of-life assessments are necessary components in evaluating incontinence therapies.
Episodes of Incontinence and Other Urinary SymptomsResults:There was a significant treatment effect for a number of incontinent episodes. In the intervention group, 61% had a 50% or greater reduction in episodes ...
Real-World Evidence From a Digital Health Treatment ...This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI.
Potential of AI-Driven Chatbots in UrologyArtificial intelligence (AI) chatbots have emerged as a potential tool to transform urology by improving patient care and physician efficiency.
The future of patient education: A study on AI‐driven ...ChatGPT demonstrated the ability to provide accurate and comprehensive responses within the context of urinary incontinence queries.
Digital health treatment program found safe, effective for ...Data from a real-world evidence study support the safety and effectiveness of the Leva Pelvic Health System, a digital health treatment ...
Patient-facing chatbots: Enhancing healthcare accessibility ...This study investigates patient attitudes toward healthcare's newest digital assistant, the chatbot, and perceptions regarding healthcare access.
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